FDA Device recall Z-1480-2022
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
- FDA Device
- Class II
- ongoing
- Published 2022-08-03
On 2022-08-03 the FDA classified a Class II recall of Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) by Medtronic Cardiac Rhythm And Heart Failure Crhf, citing manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1480-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-11-05 |
| Published | 2022-08-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Cardiac Rhythm And Heart Failure Crhf |
| Distribution | US |
Product
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
Reason
Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.
Identifiers
| code_info | GTIN 00763000178178, Serial Numbers: RTK601865S, RTK601825S, RTK601828S |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1480-2022%22
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